Manager (Audits & Inspections)
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Hobson Prior are working with a world-wide biopharmaceutical company who are currently recruiting for a Manager (Audits & Inspections) to join them on a permanent basis in Oxford. As the Manager you will lead and participate in various types of GCP/GLP compliance audits for the organisation's development programs.
- Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks.
- Co-operate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA and monitoring successful completion of action items.
- Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations.
- Assist in managing and training external auditors ensuring compliance with the organisation's auditing standards and procedures.
- Provide pertinent data to support quality and compliance metrics and trending.
- You will assist in the planning of clinical quality audit programs.
- Develop and maintain study specific audit plans and audit certificates.
- Participate in strategic planning of organizational activities, as required.
- Support inspection management lead to maintain R&D inspection readiness at times.
- Partake in regulatory agency inspection activities pertinent to R&D.
- Ability to manage multiple priorities simultaneously and work efficiently in a fast-paced culture.
- Strong and clear understanding of Good Clinical Practices.
- Strong knowledge of applicable global regulatory requirements.
- Must be disciplined, detail orientated and excel in personal time management.
- Bachelor's Degree in business or Life sciences is required, advance degree is preferred.
- Industry certification in Quality Assurance is preferred but not required.
- You will have a minimum of 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections.
- GCP audit experience is required, GVP and GLP experience is valuable but is not essential.
- Knowledge/understanding of the perspectives of regulatory agencies.
- Domestic and international travel is required.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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